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| Product NDC Code | 0135-0737 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Parodontax active gum repair breath freshener |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | DENTAL | ||||||
| Dosage Form | PASTE | ||||||
| RxCUI drug identifier | 416784 | ||||||
| Application Number | M022 | ||||||
| Labeler Name | Haleon US Holdings LLC | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Stannous fluoride 0.454% (0.15% w/v fluoride ion)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing. to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established. children under 2 years of age: Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin, zinc chloride, carrageenan
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses aids in the prevention of dental cavities. helps control bleeding gums. helps interfere with harmful effects of plaque associated with gingivitis.
Purpose
Information about the drug product’s indications for use.Purposes Anticavity Antigingivitis
Spl product data elements
Usually a list of ingredients in a drug product.parodontax Active Gum Repair Breath Freshener stannous fluoride GLYCERIN POLYETHYLENE GLYCOL 400 HYDRATED SILICA SODIUM TRIPOLYPHOSPHATE ANHYDROUS SODIUM LAURYL SULFATE TITANIUM DIOXIDE POLYACRYLIC ACID (250000 MW) COCAMIDOPROPYL BETAINE SACCHARIN SODIUM ZINC CHLORIDE CARRAGEENAN STANNOUS FLUORIDE FLUORIDE ION
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel NEW parodontax DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE ACTIVE GUM REPAIR HELPS REVERSE SIGNS OF EARLY GUM DAMAGE BREATH FRESHENER BREATH CLEANSE TECHNOLOGY* NET WT 3.4 OZ (96.4 g) 62000000203673 – Front Carton Parodontax Active Gun Repair BF 3.4 oz (96.4 g)
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Additional information ALWAYS FOLLOW THE LABEL parodontax ACTIVE GUM REPAIR Bleeding gums and bad breath can be a sign of early gum problems. New parodontax Active Gum Repair Breath Freshener is a daily toothpaste that helps reverse signs of early gum damage and uses Breath Cleanse Technology* to purify bad breath instead of just masking it. It is specially formulated to kill plaque bacteria at the gumline to help keep the gum seal tight and prevent early gum problems. Its Breath Cleanse Technology* utilizes zinc, an antibacterial ingredient scientifically proven to purify gases that cause bad breath. *compared to parodontax Clean Mint toothpaste Distributed by: GSK Consumer Healthcare Warren, NJ 07059 Made in Germany Trademarks owned or licensed by GSK. ©2023 GSK or licensor.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. this product is specially formulated to help prevent staining. do not store above 25ºC (77ºF)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-855-328-5202
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks. you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks. you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API